[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07680023":3,"trial-entities:NCT07680023":148,"trial-summary:NCT07680023":152},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":79,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":15,"eligibility_criteria":93,"std_ages":120,"locations":123,"central_contacts":139,"overall_officials":142,"references":146,"see_also_links":147},"NCT07680023","IRB00151720","Amnion Membrane Powder Mohs Study","A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites","NOT_YET_RECRUITING","2027-10","2026-06","2026-07-01","2026-10","Wake Forest University Health Sciences","OTHER",false,"The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.","The primary objective of this prospective, non-randomized, controlled study is to assess the safety of the human amnion membrane powder for enhanced wound healing properties in patients undergoing Mohs surgery resulting in full thickness wounds. The secondary objective is to evaluate the efficacy of the product relative to the standard of care treatment in a control cohort of subjects. The treatment site will be the wound created by the Mohs surgery in the treatment group. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.",[19],"Wound Heal",[21,22,23],"MOHS surgery","amnion membrane powder","scalp wound healing","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},20,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Amnion Membrane Powder","amnion membrane power dose of 0.26 mg\u002Fmm3 applied during MOHS scalp surgery",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Standard of Care","aquaphor ointment applied during MOHS scalp surgery",[38],[42,46,49,52,55,59,61,63,65,67,69,71,73,75,77],{"measure":43,"description":44,"timeFrame":45},"Number of Participants with Infection","Number of participants that developed a wound infection","Through week 16",{"measure":47,"description":48,"timeFrame":45},"Number of Participants with Allergic Reaction","Number of participants with an allergic reaction to the intervention",{"measure":50,"description":51,"timeFrame":45},"Number of Treatment-Related Adverse Events","Number of treatment-related adverse events",{"measure":53,"description":54,"timeFrame":45},"Number of Unscheduled Visits for Wound Bleeding","Number of participants that had an unscheduled visit for wound bleeding",{"measure":56,"description":57,"timeFrame":58},"Pain Score","Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.","Baseline",{"measure":56,"description":57,"timeFrame":60},"Week 1",{"measure":56,"description":57,"timeFrame":62},"Week 2",{"measure":56,"description":57,"timeFrame":64},"Week 3",{"measure":56,"description":57,"timeFrame":66},"Week 4",{"measure":56,"description":57,"timeFrame":68},"Week 5",{"measure":56,"description":57,"timeFrame":70},"Week 6",{"measure":56,"description":57,"timeFrame":72},"Week 7",{"measure":56,"description":57,"timeFrame":74},"Week 8",{"measure":56,"description":57,"timeFrame":76},"Week 12",{"measure":56,"description":57,"timeFrame":78},"Week 16",[80,83,86],{"measure":81,"description":82,"timeFrame":45},"Time Until Wound Closure","Number of days until wound was completely closed",{"measure":84,"description":85,"timeFrame":45},"Time Until of Wound Closure","Number of days until wound was fully sealed",{"measure":87,"description":88,"timeFrame":89},"Percentage of Re-epithelialization","Percentage of the wound with re-epithelialization","Week 1, week 4, week 8, week 12, week 16","ALL","18 Years",null,{"inclusion":94,"exclusion":101,"raw_text":119},[95,96,97,98,99,100],"The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.","The subject is willing to complete all follow-up evaluations required by the study protocol.","The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate","The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.","The subject and\u002For guardian is\u002Fare able to read and understand instructions and give informed, voluntary, written consent.","The subject is able and willing to follow the protocol requirements.",[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"The subject's wound site is smaller than 4cm2.","The subject's wound site does not extend to the subgalea.","The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology","The subject has a microbiologically proven pre-existing local or systemic bacterial infection.","The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.","Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and\u002For other interventional procedure that would preclude the indicated procedure.","Hepatic disease or altered liver function as defined by ALT or AST value \\> 3 times the upper limit of normal and\u002For T. Bilirubin \\>1.5 mg\u002FdL at screening.","Renal disease or altered renal function as defined by serum creatinine \\> 2 mg\u002FdL at screening, or ESRD.","Hemoglobin \\\u003C10.0 or \\>19.0 g\u002FdL","Untreated coagulopathy or platelet disorder, or INR \\> 1.6, PTT \\> 38 sec; PLT \\\u003C 50,000 at screening.","The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c \\>10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and \u002For malnourishment with an albumin \\\u003C 2.5.","The subject currently uses illicit substances or has drug or alcohol dependency.","The subject is unable to follow the protocol.","The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)","The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.","The subject is pregnant or lactating or intends to become pregnant during the study.","The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.","Inclusion Criteria:\n\n* The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.\n* The subject is willing to complete all follow-up evaluations required by the study protocol.\n* The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate\n* The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.\n* The subject and\u002For guardian is\u002Fare able to read and understand instructions and give informed, voluntary, written consent.\n* The subject is able and willing to follow the protocol requirements.\n\nExclusion Criteria:\n\n* The subject's wound site is smaller than 4cm2.\n* The subject's wound site does not extend to the subgalea.\n* The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology\n* The subject has a microbiologically proven pre-existing local or systemic bacterial infection.\n* The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.\n* Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and\u002For other interventional procedure that would preclude the indicated procedure.\n* Hepatic disease or altered liver function as defined by ALT or AST value \\> 3 times the upper limit of normal and\u002For T. Bilirubin \\>1.5 mg\u002FdL at screening.\n* Renal disease or altered renal function as defined by serum creatinine \\> 2 mg\u002FdL at screening, or ESRD.\n* Hemoglobin \\\u003C10.0 or \\>19.0 g\u002FdL\n* Untreated coagulopathy or platelet disorder, or INR \\> 1.6, PTT \\> 38 sec; PLT \\\u003C 50,000 at screening.\n* The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c \\>10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and \u002For malnourishment with an albumin \\\u003C 2.5.\n* The subject currently uses illicit substances or has drug or alcohol dependency.\n* The subject is unable to follow the protocol.\n* The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)\n* The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.\n* The subject is pregnant or lactating or intends to become pregnant during the study.\n* The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.",[121,122],"ADULT","OLDER_ADULT",[124],{"facility":125,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":136},"Atrium Health Wake Forest Baptist","Winston-Salem","North Carolina","27157","United States",[131],{"name":132,"role":133,"phone":134,"email":135},"Mary-Clare Day","CONTACT","336-713-1343","maryclare.day@advocatehealth.org",{"lat":137,"lon":138},36.09986,-80.24422,[140],{"name":132,"role":133,"phone":134,"email":141},"Maryclare.Day@advocatehealth.org",[143],{"name":144,"affiliation":125,"role":145},"Christine Ahn, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":149,"biomarkers":151},[150],"Wound healed",[],{"nct_id":4,"found":153,"summary":154,"prompt_version":164},true,{"design":155,"status":156,"heading":157,"summary":158,"follow_up":159,"word_count":160,"commitments":161,"compensation":162,"drugs_mentioned":163},"This is an interventional study, meaning participants will receive a specific treatment. It is a non-randomized, controlled study with a planned enrollment of 20 participants.","completed","Amnion Membrane Powder for Scalp Wound Healing After Mohs Surgery","This study is testing a product called Amnion Membrane Powder to see if it helps wounds heal better after Mohs surgery on the scalp. You could be eligible if you are at least 18 years old and need Mohs surgery on your scalp, resulting in a wound that is at least 4 square centimeters and extends to the subgalea (meaning all subcutaneous fat is removed). Researchers will compare Amnion Membrane Powder to standard care (Aquaphor ointment) to see if it causes fewer infections, allergic reactions, or other side effects. The study aims to enroll 20 participants, but its current recruitment status is unclear.","Participants will be followed for infection, allergic reactions, and adverse events through week 16.",103,"You would need to complete all follow-up evaluations required by the study protocol. The primary endpoints are measured through week 16.","Not stated in the trial record.",[34],"v2"]